Left atrial appendage occlusion for patients with valvular diseases without atrial fibrillation (the OPINION Study):

Fan Ju1, Xin Yuan1, Hansong Sun2

  • 1Department of Cardiac Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital, Xicheng District, Beijing, China.

BMJ Open
|February 7, 2024
PubMed

Insights

Surgical left atrial appendage occlusion (SLAAO) during valve surgery may prevent long-term stroke in patients without atrial fibrillation (AF). This trial investigates SLAAO

Area of Science:

  • Cardiovascular Surgery
  • Neurology
  • Clinical Trials

Background:

  • Atrial fibrillation (AF) is a major cause of perioperative stroke in aortic and mitral valve surgery.
  • Previous studies on surgical left atrial appendage occlusion (SLAAO) are retrospective and may have confounding factors.
  • Opportunistic SLAAO during cardiac surgery is being investigated for stroke prevention in specific patient groups.

Purpose of the Study:

  • To test the hypothesis that opportunistic SLAAO can prevent long-term stroke after cardiac surgery.
  • To evaluate the efficacy of SLAAO in patients undergoing mitral or aortic valve surgery without a history of AF and with a CHA2DS2-VASc score of 2 or higher.
  • To assess the impact of SLAAO on stroke and cardiovascular mortality.

Main Methods:

  • A single-blinded, multicentre, randomised controlled trial involving 2118 patients.
  • Patients undergoing aortic or mitral surgery without AF will be randomized 1:1 to intervention (SLAAO) or control groups.
  • The primary outcome is a composite of new ischemic stroke, transient ischemic attack, and cardiovascular mortality over 1 year.

Main Results:

  • This section is to be filled once the trial results are available.
  • The study is currently recruiting patients and has not yet produced results.
  • Data collection and analysis will occur post-completion of patient follow-up.

Conclusions:

  • This trial will provide crucial data on the effectiveness of SLAAO in preventing stroke in a high-risk surgical population.
  • Findings will inform clinical practice regarding the prophylactic use of SLAAO during valve surgery.
  • The study aims to reduce the incidence of stroke and improve long-term outcomes for cardiac surgery patients.
Abstract

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